A VMP is going to start with a purpose, a scope, and a summary of the overall validation strategy.
These sections will explain which of the aforementioned approaches we are taking.
Validation Strategy
The validation strategy likely includes a definition of:
- The Life Cycle Approach to Validation (Concept, Project, Operation and Retirement)
- Defining Requirements
- Basing the Validation on a Risk Assessment
- Defining Hardware
- Defining Software
- Defined Project Inputs
- Defined Project Outputs
- Defined Acceptance Strategies
VMP Core
The core of the VMP will include the deliverables of the validation activities and a conclusion of the state of the systems validation and if it is fit for use.
In addition, the VMP may include information on:
- Security
- Support
- Business Continuity
- Disaster Recovery
- Change Management
- Revalidation Frequency and Requirements
- A Retirement Strategy
- A summation of Training and Supportive Documentation (such as equipment specific SOP’s)